Higher Diploma in Quality Systems Validation with Data Analytics

HIGHER DIPLOMA IN QUALITY SYSTEMS VALIDATION WITH DATA ANALYTICS

LOCATION

MTU Bishopstown Campus, Cork

COURSE FEEENQUIRIES ENQUIRIES

Dr Gráinne Conneely Dr Gráinne Conneely 021 433 5870 021 433 5870 Grainne.conneely@mtu.ieE: Grainne.conneely@mtu.ie Funding Option Available

COURSE CODE SQSDA_8_Y5

(LEVEL 8)

Register with Springboard https://springboardcourses.ie

Springboard+ Application Procedure

You must register with Springboard https://springboardcourses. ie/ and apply for the Higher Diploma in Quality Systems Validation with Data Analytics. Once your application on the Springboard website has been accepted, MTU Admissions office in Cork will be in contact with you to complete your registration.

Admission requirements

Target learners on this programme will include those who wish to upskill and reskill from closely related disciplines as well as upskilling those already in employment in related industrial sectors with complementary qualifications. Each candidate will be assessed individually on their own merits.

Aim

Higher Diploma in Quality Systems Validation with Data Analytics is a 60 credit, 12-month programme. The course is industry focussed to address scientific skills gaps within the Pharmaceutical, Biopharmaceutical, Food, Beverage, Water & MedTech sectors. Graduates will have an expert knowledge on the methodologies to ensure validation and associated data analytics. The regulatory and validation sections of the course provide an overview of the regulatory requirements for industry, including the requirements on validation of software systems, electronic records and signatures, Data Integrity and Quality Risk Management as applied to Computer Systems Validation.

Content

The programme adopts a practical, hands on, approach to learning, where all modules are fully assessed using continuous assessment methods. There is no formal end of semester written examination. The programme is delivered over two 30 credit semesters. Each taught semester has several modules – Semester 1: Data Analytics and Chemometrics, Validation of Quality Systems, LIMS & SQC, Regulatory Affairs and Auditing, Professional Development and Communication, Management and Leadership. The Experimental Industrial Project and Regulatory Industrial Placement takes place in Semester 2 of the programme where students can be placed in industry to complete an industry related project.

Entry Requirements

Open to graduates and experienced personnel with a Level 8 qualification in science, life science, business, engineering, or related disciplines. Applicants with a Level 7 in a Science/ Engineering discipline AND extensive relevant industrial experience or training may be considered via the University’s recognition of prior learning (RPL) policy and process.

Award

Higher Diploma in Quality Systems Validation with Data Analytics (60 ECTS, Level 8 on the National Framework of Qualification).